Sterilizing cabinet filter cartridge

This application is a continuation of U.S. patent application Ser. No. 17/062,976 filed Oct. 5, 2020, which is a continuation of U.S. patent application Ser. No. 16/550,942 filed Aug. 26, 2019, now U.S. Pat. No. 10,792,602, which is a continuation of U.S. patent application Ser. No. 15/946,442 filed Apr. 5, 2018, now U.S. Pat. No. 10,391,435, which claims the benefit of U.S. Provisional Applications No. 62/482,170 filed Apr. 5, 2017, 62/482,683 filed Apr. 6, 2017, and 62/483,008 filed Apr. 7, 2019, and which is a continuation-in-part of U.S. patent application Ser. No. 15/461,895 filed Mar. 17, 2017, now U.S. Pat. No. 10,226,728, which is a continuation of U.S. patent application Ser. No. 14/584,751 filed Dec. 29, 2014, now U.S. Pat. No. 9,616,368, which is a continuation-in-part of U.S. patent application Ser. No. 14/167,691 filed Jan. 29, 2014, now U.S. Pat. No. 10,245,335, the entire disclosure of each is hereby expressly incorporated by reference. U.S. patent application Ser. No. 17/062,976 is also a continuation of U.S. patent application Ser. No. 16/229,995 filed on Dec. 21, 2018, which is a continuation of U.S. patent application Ser. No. 15/662,873 filed on Jul. 28, 2017, now U.S. Pat. No. 10,188,762, which is a continuation of U.S. patent application Ser. No. 14/675,048 filed on Mar. 31, 2015, now U.S. Pat. No. 9,724,438, which is a continuation-in-part of U.S. patent application Ser. No. 14/167,691 filed on Jan. 29, 2014, now U.S. Pat. No. 10,245,335 and U.S. patent application Ser. No. 14/584,751 filed on Dec. 29, 2014, now U.S. Pat. No. 9,616,368, which is a continuation-in-part of U.S. application Ser. No. 14/167,691 filed on Jan. 29, 2014, now U.S. Pat. No. 10,245,335, the entire disclosure of each is hereby expressly incorporated by reference.

This application is a continuation of U.S. patent application Ser. No. 17/679,221, filed on Feb. 24, 2022, which is a continuation of U.S. patent application Ser. No. 16/809,080 filed on Mar. 4, 2020, now U.S. Pat. No. 11,305,222, which is a continuation of Ser. No. 16/290,510 filed on Mar. 1, 2019, now U.S. Pat. No. 10,675,576, which is a continuation of U.S. patent application Ser. No. 15/461,895 filed on Mar. 17, 2017, now U.S. Pat. No. 10,226,728, which is a continuation of Ser. No. 14/584,751 filed on Dec. 29, 2014, now U.S. Pat. No. 9,616,368, which is a continuation-in-part of Ser. No. 14/167,691 filed on Jan. 29, 2014, now U.S. Pat. No. 10,245,335, the entire disclosure of each is hereby expressly incorporated by reference.

Exemplary embodiments of the present invention relate to a method and apparatus for sterilization and more particularly to a method and apparatus for sterilization of instruments.

Sterilization is a term referring to any process that eliminates (removes) or kills microbial life, including transmissible agents (such as fungi, bacteria, viruses, or spore forms) present on a surface, or contained in a fluid, or in medication, or in a compound such as biological culture media. Sterilization can be achieved by applying heat, chemicals, irradiation, high pressure, and filtration or combinations thereof.

In general, surgical instruments and medications that enter an already aseptic part of the body (such as the bloodstream, or penetrating the skin) must be sterilized to a high sterility assurance level. Examples of such instruments include scalpels, hypodermic needles and implantable medical devices (IMD), such as artificial pacemakers.

A widely used method for heat sterilization is the autoclave, sometimes referred to as a converter. Autoclaves commonly use steam heated to 121-134° C. To achieve a degree of sterility, a holding time of at least 15 minutes at 121° C. at 100 kPA, or 3 minutes at 134° C. at 100 kPa is required. Additional sterilizing time is usually required for liquids and instruments packed in layers of cloth, as they may take longer to reach the required temperature.

One method of sterilization involves passing steam through a cabinet. For effective sterilization, steam needs to penetrate the cabinet load uniformly. Accordingly, the cabinet must not be overcrowded, and the lids of bottles and containers must be left ajar. During the initial heating of the chamber, residual air must be removed. Indicators should be placed in the most difficult places for the steam to reach to ensure that steam actually penetrates there.

A filter is typically placed over the vent to keep particles or extraneous materials from entering the cabinet before, during or after the sterilizing process. Once the sterilizing process is completed the filter needs to be removed and inspected by medical professionals to verify the integrity of the sterilizing process was maintained. If it is discovered during inspection that the filter did not remain intact, the sterilizing process has to be repeated with a new filter.

In view of the foregoing, it is an object of the present invention to provide a method and apparatus for sterilization.

A first exemplary embodiment of the present invention provides a sterilizing cabinet assembly. The sterilizing cabinet assembly includes a cabinet having an access port and a door connected to the cabinet, the door moveable between an open position permitting passage through the access port to an interior of the cabinet and a closed position precluding passage through the access port. This embodiment further includes at least one of the cabinet and the door having a vent port and a primary filter overlying the vent port and forming a sealed interface with an adjacent portion of the one of the cabinet and the door. This embodiment further includes a secondary filter overlying at least a portion of the primary filter. In this embodiment, the secondary filter forms an independent sealed interface with the sterilizing cabinet or the primary filter.

A second exemplary embodiment of the present invention provides a method for placing filters. The method includes disposing a primary filter to occlude a vent port of a sterilizing cabinet forming a first sealed interface with the sterilizing cabinet. The method further includes forming a second sealed interface between a confirmatory filter and at least a portion of one of the sterilizing cabinet and the primary filter, a portion of the confirmatory filter overlying a portion of the primary filter. In this embodiment, the second sealed interface is independent of the first sealed interface.

A third exemplary embodiment of the present invention provides a sterilizing assembly. The sterilizing assembly includes a sterilizing cabinet and a first tray and a second tray sized to be retained within the cabinet. The sterilizing assembly further includes at least one removable spacer intermediate the first tray and the second tray, the spacer being sterilizable and vertically separating the first tray and the second tray by a given height, the spacer inhibiting lateral displacement of the first tray relative to the second tray, wherein the given height is sufficient to permit a passage of a sufficient amount of a sterilizing agent between the first tray and the second tray for a predetermined time.

A fourth exemplary embodiment of the present invention provides a method of loading a sterilizing cabinet. The method includes loading a sterilizable first pan and a sterilizable second pan within the sterilizing cabinet. The method further includes placing a removable and sterilizable spacer between the first pan and the second pan, the spacer (i) providing at least one of a predetermined vertical spacing between the first pan and the second pan and (ii) inhibiting horizontal displacement of the first pan relative to the second pan.

A fifth exemplary embodiment of the present invention provides a method of sterilizing. The method includes loading a tray retaining a surgical instrument in a sterilization cabinet and sealing a primary filter relative to a vent port in the sterilization cabinet. The method further includes sealing a secondary filter relative to the vent port and independent of the sealed primary filter and passing a sterilizing agent through the secondary filter and the primary filter.

A sixth exemplary embodiment of the present invention provides a sterilizable pan assembly. The sterilizable pan assembly includes a first sterilizable pan having an open top, a closed bottom and a pair of projecting spacer legs and a second sterilizable pan having an open top and closed bottom. The sterilizable pan assembly further includes the spacer legs configured to releasably engage a portion of the second pan and maintain a predetermined vertical spacing between the bottom of the first pan and the top of the second pan.

A seventh exemplary embodiment of the present invention provides a filtering assembly. The filtering assembly including a primary filter holding portion for holding a primary filter for overlying a vent port and forming a sealed interface with a sterilizing cabinet. The filter assembly further includes a secondary filter holding portion for holding a secondary filter, moveably attached to the primary holding portion for overlying the primary filter holding portion and forming a sealed interface with the primary filter holding portion.

An eighth exemplary embodiment of the present invention provides a method for verifying sterilization. The method includes performing a sterilization cycle in a sterilization device. The method further includes removing a secondary filter that is overlying a primary filter with a second sealed interface with the primary filter from the sterilizing device such that the primary filter maintains a sealed interface with a vent port of the sterilizing device and examining the secondary filter to verify the integrity of the sterilization cycle in the sterilizing device.

A ninth exemplary embodiment of the present invention provides a sterilizing cabinet assembly. The sterilizing cabinet assembly includes a cabinet having an access port and a door connected to the cabinet, the door moveable between an open position permitting passage through the access port to an interior of the cabinet and a closed position precluding passage through the access port. The sterilizing cabinet assembly further includes at least one of the cabinet and the door having a vent port and a filter overlying the vent port and forming a sealed interface with an adjacent portion of the one of the cabinet and the door.

A tenth exemplary embodiment of the present invention provides a method of placing filters. The method includes disposing a primary door to occlude a vent port of a sterilizing cabinet, the primary door comprising an edge portion and an internal portion, the internal portion comprising a plurality of openings. The method further includes disposing a filter over the primary door to occlude the vent port of the sterilizing cabinet and disposing a secondary door over the filter and the primary door to occlude the vent port of the sterilizing cabinet forming a sealed interface with the filter, the primary door and the sterilizing cabinet.

An eleventh exemplary embodiment of the present invention provides a method of verifying sterilization. The method includes performing a sterilization cycle in a sterilizing device. The method further includes removing a secondary door that is overlying a filter with a second sealed interface with the filter from the sterilizing device. The method still further includes examining the filter to verify the integrity of the sterilization cycle in the sterilizing device.

A twelfth exemplary embodiment provides a sterilizing cabinet assembly including a cabinet having an access port and a bottom, the bottom configurable to induce condensate to flow on the bottom to pass through a vent port. The sterilizing cabinet assembly further includes a door connected to the cabinet, the door moveable between an open position permitting passage through the access port to an interior of the cabinet and a closed position precluding passage through the access port, and at least one of the cabinet and the door having the vent port. The sterilizing cabinet assembly can also include a filter overlying the vent port to form a sealed interface with an adjacent portion of the one of the cabinet and the door.

A thirteenth exemplary embodiment provides a method of sterilizing. The method includes disposing a primary door to occlude a vent port of a sterilizing cabinet, the primary door comprising an edge portion and an internal portion, the internal portion comprising a plurality of openings, the sterilizing cabinet having a bottom configurable to induce a flow of condensate on the bottom to the vent port. The method also includes disposing a filter over the primary door to occlude the vent port of the sterilizing cabinet. The method further includes performing a sterilizing cycle on the sterilizing cabinet, and draining resulting condensate through the filter.

A fourteenth exemplary embodiment provides a method for sterilizing. The method includes generating a condensate in a sterilizing cabinet, the sterilizing cabinet being within a closed autoclave, and draining the condensate through a vent port of the sterilizing cabinet prior to opening the autoclave. It is contemplated the vent port can include a filter.

A further embodiment provides a sterilizing cabinet assembly, including a cabinet having an access port and a bottom; a door connected to the cabinet, the door moveable between an open position permitting passage through the access port to an interior of the cabinet and a closed position precluding passage through the access port; at least one of the cabinet and the door having a vent port, wherein the bottom induces condensate on the bottom to flow to the vent port; and a filter overlying the vent port and forming a sealed interface with an adjacent portion of the one of the cabinet and the door.

A method of sterilizing, is provided including occluding a vent port of a sterilizing cabinet with a filter, the sterilizing cabinet having an internal inclined surface to induce a condensate flow to the vent port; performing a sterilization cycle on the sterilizing cabinet; and draining at least a portion of a condensate formed in the sterilization cycle along the inclined surface to pass from the sterilizing cabinet through the filter.

Another method includes locating a sterilizing cabinet in an autoclave; applying a sterilization cycle to the sterilizing cabinet in the autoclave; and draining along an inclined surface in the sterilizing cabinet at least a portion of a condensate from the sterilizing cabinet during the sterilization cycle.

Another embodiment provides a filter cartridge for a sterilizing cabinet, the filter cartridge comprising a first gasket comprising a rigid or flexible edge portion and forming a frame defining a hollow center portion, a first filter comprising a porous material for maintaining a sterilized condition in the sterilizing cabinet and passing gaseous materials through the porous material, wherein the first filter is affixed to the first gasket, and a second filter comprising a porous material for maintaining a sterilized condition in the sterilizing cabinet and passing gaseous materials through the porous material, wherein the second filter is either affixed to the first filter or the first gasket opposite the first filter, and wherein the filter cartridge provides sufficient structural integrity to form a sealing interface with a confronting surface of the sterilizing cabinet.

Yet another embodiment provides a filter cartridge for a sterilizing cabinet, the filter cartridge comprising a first gasket comprising a rigid or flexible beaded edge portion and forming a frame defining a hollow center portion, and a first filter comprising a porous material for maintaining a sterilized condition in the sterilizing cabinet and passing gaseous materials through the porous material, wherein the first filter is affixed to the first gasket, and wherein the filter cartridge is removeable in one piece following a sterilization cycle of a sterilizer.

A further embodiment provides filter cartridge for a sterilizing cabinet, the filter cartridge comprising a first filter comprising a porous material for maintaining a sterilized condition in the sterilizing cabinet and passing gaseous materials through the porous material, a first gasket comprising a rigid or flexible edge portion and forming a frame defining a hollow center portion, the first gasket being coextensive or permanently affixed to the first filter, and a second filter comprising a porous material for maintaining a sterilized condition in the sterilized cabinet and passing gaseous materials through the porous material, wherein the second filter is coextensive or permanently affixed to the first gasket opposite the first filter. The filter cartridge in an embodiment is disposable and single use. In an embodiment, the first filter comprises a perimeter edge, wherein the perimeter edge is folded onto itself to form the first gasket. In another embodiment, the first filter comprises a perimeter edge, and the first gasket is a beaded edge spaced a given distance from the perimeter edge of the first filter. The first filter in an embodiment includes different thicknesses through its cross-section. In an embodiment, the first filter is the same material as the second filter. The filter cartridge is, in an embodiment, removeable in one piece following a sterilization cycle of a sterilizer. The filter cartridge can comprise a steam exposure indicator disposed on an outer surface of one of the first filter and the second filter. In an embodiment, the filter cartridge provides sufficient structural integrity to form a sealing interface with a confronting surface of the sterilizing cabinet and with a confronting surface of a door of the sterilizing cabinet. The filter cartridge in an embodiment further comprises at least a partial seal between the first filter and the first gasket, wherein the partial seal is formed before the sealing interface is formed between the filter cartridge and the confronting surface of the sterilizing cabinet, and wherein extraneous particles are prevented from passing between the at least partial seal between the first filter and the first gasket. In yet another embodiment, the filter cartridge comprises a seal between the first filter and the first gasket and between the second filter and the first gasket, wherein each seal is formed before the sealing interface is formed between the filter cartridge and the confronting surface of the sterilizing cabinet, and wherein extraneous particles are prevented from passing along the seal between the first filter and the first gasket and between the second filter and the first gasket.

The following will describe embodiments of the present invention, but it should be appreciated that the present invention is not limited to the described embodiments and various modifications of the invention are possible without departing from the basic principle. The scope of the present invention is therefore to be determined solely by the appended claims.

In the medical field, it is of the utmost importance that medical instruments are sterilized prior to any medical procedure. This drastically helps prevent the spread of infectious materials. In the marketplace, there are a wide variety of devices that provide for sterilization of medical instruments through the use of a sterilizing agent, such as steam. Instrument trays can be wrapped in a cloth or paper that acts as a filter, allowing the tray to be sterilized, then delivered to the operating room. Alternatively, a rigid container can contain the instrument tray. Typically, the device (e.g., a rigid container) contains a vent for venting the steam used to sterilize the contents of the device. A disposable filter usually covers these vents. The filters have two major purposes. First, they prevent extraneous materials from entering the sterilizing device during and after the sterilization cycle. Second, they allow sterilizing steam to enter and exit the sterilizing device.

However, in order to check that the integrity of the sterilization cycle has been maintained a person (usually a medical technician) must verify that there are no holes or other types of rips in the filter. This is done by removing the filter from the sterilizing device and visually inspecting the filter. This creates an inherent time period wherein the sterilized instruments can be contaminated by extraneous materials that enter the sterilizing device through the now open and uncovered vents. An object of exemplary embodiments of this disclosure provide a solution to this problem.

Referring to, is a front view of sterilizing cabinet. It should be noted that embodiments of the present invention are not limited to the particular configuration of sterilizing cabinet.

The term sterilizing cabinetencompasses any device capable of sterilizing. The term also includes sterilizing cabinets for sterilizing medical instruments, surgical devices and the like.

Sterilizing cabinetincludes door or doors, vents, filter holder, primary filter, secondary filter, sterilizing cabinet frameand legs. Door or doorsare able to open and close for access to the interior of sterilizing cabinet. Door or doorsare physically connected to sterilizing cabinet frame. Door or doorscan be attached through the use of a hinge or hinges which allows the doors to swing open. Alternatively, door or doorscan be removable from sterilizing cabinetthrough the use of clamps (not shown in). It should be appreciated that exemplary embodiments of door or doorsinclude any mechanism that allows for door or doorsto move from an open position to a closed position to provide access to the interior of sterilizing cabinet.

Sterilizing cabinetin this embodiment provides for four vents. However, it should be appreciated that exemplary embodiments of sterilizing cabinetare not limited to four vents. Exemplary embodiments of sterilizing cabinetcan include one or more vents. Two ventson the top of sterilizing cabinetand two ventson the bottom of sterilizing cabinet. Ventsprovide numerous small openings for the passage of sterilizing steam. The small openings in ventscan be holes or slits. Alternatively, ventscan be fenestrated.

Primary filterin conjunction with filter holdercovers vent. Primary filterwith filter holderforms a seal with the adjacent portions of sterilizing cabinetsuch that during the operation of a sterilizing cycle, any sterilizing steam that passes through the ventmust then pass through primary filter. Primary filtercan be made of a very thin paper. Exemplary embodiments provide that primary filtercan be made of any porous material that (1) allows for the passage of sterilizing steam from sterilizing cabinetand (2) prevents extraneous materials from passing through primary filterand entering vent. Primary filteris removable from sterilizing cabinetand is typically replaced with a new filter following each sterilizing cycle.

Secondary filterresides on top of primary filterin filter holder. Secondary filtercovers primary filterand forms a seal with primary filterthrough filter holdersuch that any sterilizing steam that passes through the ventmust then pass through primary filterand secondary filter. Secondary filtercan be made of a very thin paper. Secondary filtercan be made of any porous material that (1) allows for the passage of sterilizing steam from sterilizing cabinetand primary filterand (2) prevents extraneous materials from passing through secondary filter.

Exemplary embodiments of this disclosure provide for secondary filterto form a sealed periphery with primary filter. In another exemplary embodiment the sealed interface between the primary filterand the adjacent portion of either the sterilizing cabinetis independent of an interface between secondary filterand primary filter. One exemplary arrangement provides for primary filterand secondary filterto be coextensive. In another exemplary embodiment primary filterand secondary filterhave different filter properties. For instance, primary filterand secondary filtermay filter different elements of the sterilizing agent which exits sterilizing cabinetduring a sterilization cycle. In an alternative exemplary embodiment primary filterand secondary filterhave similar filter properties. Another exemplary embodiment provides that primary filterand secondary filterare different colors.

In yet another exemplary embodiment, primary filtermay be the only filter that covers vent. Here, primary filteris removeably held or maintained in place over ventby filter holder. In this embodiment, there is no secondary filter. Primary filterforms a seal with the adjacent portions of sterilizing cabinetsuch that during the operation of a sterilizing cycle, any sterilizing steam that passes through the ventmust then pass through primary filter. Again, in this embodiment, primary filtercan be made of any porous material that (1) allows for the passage of sterilizing steam from sterilizing cabinetand (2) prevents extraneous materials from passing through primary filterand entering vent. Primary filteris removable from sterilizing cabinetand is typically replaced with a new filter following each sterilizing cycle.

Legsreside on the bottom of sterilizing cabinetand provide spacing between the surface which sterilizing cabinetrests and the bottom primary filter, secondary filterand filter holder.

provides a top view of sterilizing cabinetshowing ventcovered by filter holder, primary filter, secondary filter, sterilizing cabinet frameand hingeof filter holder. Hingewith filter holderallows a portion of filter holderto swing open about hingesuch that primary filterand secondary filtercan be removed independent of one another. In other words, filter holderallows for secondary filterto be released and removed from filter holderwhile simultaneously maintaining primary filter'sseal with sterilizing cabinetover vent.

shows a side view of sterilizing cabinetincluding sterilizing cabinet frame, vent, primary filter, secondary filter, filter holderand hinge.

In exemplary embodiments sterilizing cabinetmay include a steam exposure indicator on either the primary filteror the secondary filterwhich designates when steam from sterilizing cabinethas passed through one of the filters. An example of one such steam exposure indicator is a tape that changes colors when exposed to steam.

provides a perspective view of sterilizing cabinetwith two ventson the top and two ventson the bottom of sterilizing cabinet.also includes primary filtersoccluding ventsand secondary filtersoverlaying primary filterswith primary filtersand secondary filterseach in filter holders.

provides a top view of sterilizing cabinetwith an alternative exemplary embodiment of filter holder. Shown inare two ventsoccluded by primary filterswhich are also covered by secondary filters. In this exemplary embodiment filter holdersdo not have a swinging hinge which allows for the individual attachment and release of primary filtersand secondary filters. In this exemplary embodiment filter holdersallow for independently removing primary filterand secondary filterthrough the use of a sliding mechanism. Secondary filtercan be removed by sliding it out of filter holderwhile maintaining primary filter'sseal with sterilizing cabinetaround vent.

In another alternative exemplary embodiment, filter holderagain does not include a swinging hinge, but allows for the placement and removal of only primary filterby a sliding mechanism. In this embodiment, there is no secondary filter. Only primary filterin conjunction with filter holderforms a sealed interface with sterilizing cabinetoccluding vents. Primary filtercan then be placed or removed by sliding into and out of filter holder.

In practice, an exemplary embodiment of a process of placing primary filterand secondary filterincludes disposing primary filterto occlude a ventof sterilizing cabinetand forming a first sealed interface with the sterilizing cabinet. The process continues by forming a second sealed interface between secondary filter(or confirmatory filter) and at least a portion of one of sterilizing cabinetand primary filter, a portion of the secondary filteroverlying a portion of the primary filter. The process can continue by passing a sterilizing agent (typically steam) through primary filterand secondary filterand vent.

Also in practice, an exemplary embodiment of a process of placing only a primary filterincludes disposing primary filterwith filter holderto occlude ventof sterilizing cabinetcreating a sealed interface with the sterilizing cabinet. The process can continue by passing a sterilizing agent (typically steam) through primary filterand vent. The process can then conclude with verifying the integrity of primary filterby either inspecting primary filterwhile it covers ventin filter holderor after it is removed from filter holder. The process may be repeated if it is determined that the integrity of primary filterwas compromised during the sterilizing process.

Exemplary embodiments of inspecting primary filterand/or secondary filtercan include visual inspection by either medical or non-medical personnel, inspecting by an electronic device or machine, or inspecting through mechanical means. Exemplary embodiments of inspecting by an electronic device or machine includes any type of device that is able to scan or image the primary filterand/or secondary filtersuch that the scanned or imaged picture of the primary filterand/or secondary filtercan be digitally viewed or examined for imperfections such as rips or cuts that would impact the integrity of the sterilization cycle. Exemplary embodiments of mechanical inspection includes any type of inspection means that physically test that the integrity of the primary filterand/or secondary filterhas been maintained.